A Study to Evaluate the Efficacy and Safety of TF0023 Spray on Subjects With Ischemic Strokes "TF0023"

Recruiting

Phase 2 Results N/A

Update History

24 Sep '16
A location was updated in Colorado Springs.
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The overall status was updated to "Not yet recruiting" at Colorado Springs Neurological Associates.
A location was updated in Englewood.
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The overall status was updated to "Recruiting" at CarePoint, P.C. dba Blue Sky Neurology.
A location was updated in Delray Beach.
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The overall status was updated to "Recruiting" at Tenet South Florida / Delray Medical Center.
A location was updated in Orlando.
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The overall status was updated to "Recruiting" at Florida Hospital Orlando.
A location was updated in Kansas City.
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The overall status was updated to "Recruiting" at Midwest Physicians Group.
A location was updated in Saint Louis.
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The overall status was updated to "Recruiting" at Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center.
A location was updated in Reno.
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The overall status was updated to "Recruiting" at Renown Medical Group.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Icahn School of Medicine at Mount Sinai (ISMMS) - Institute for Critical Care Medicine.
A location was updated in Akron.
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The overall status was updated to "Not yet recruiting" at Neurology and Neuroscience Associates.
A location was updated in Columbus.
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The overall status was updated to "Recruiting" at The Ohio State University Wexner Medical Center (OSUWMC) - Neurovascular Stroke Center.
A location was updated in Portland.
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The overall status was updated to "Recruiting" at Providence Stroke Center.
A location was updated in Abington.
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The overall status was updated to "Recruiting" at Neurovascular Associates of Abington.
A location was updated in Nashville.
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The overall status was updated to "Recruiting" at Vanderbilt University Medical Center.
A location was updated in Mansfield.
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The overall status was updated to "Recruiting" at Neurology Associates of Arlington, PA.
A location was updated in Richmond.
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The overall status was updated to "Recruiting" at VCU Medical Center.
16 Sep '16
The description was updated.
New
This randomized, double-blind (within dose), placebo-controlled, parallel group study will be conducted in 2 parts to evaluate the efficacy and safety of TF0023 spray versus placebo in functional improvement in patients with ischemic strokes. Part A will evaluate the safety and efficacy of TF0023 spray in a higher dose . Efficacy will be assessed by the change in modified Rankin Scale (mRS) score from baseline to Week 16. At Week 16, a blinded interim analysis will be performed to determine if TF0023 shows positive results with a higher proportion of patients in the TF0023 group showing a more favorable outcome compared with the placebo group. If the results are positive, then Part B will be initiated to further evaluate safety and efficacy of TF0023 spray as well as to determine the best dosing regimen for the signs and symptoms and functional improvement of patients with ischemic strokes. Part A (Proof-of-Concept) In Part A (proof-of-concept), approximately 200 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 75 will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 [50 patients] and placebo [25 patients]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer high dose of either TF0023 or placebo twice daily (approximately every 12 hours). Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the end of the study (EOS) at Week 32. That is, patients who were receiving active treatment will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit. An interim analysis will be performed using the data collected through the study up to and including the Week 16 visit. If the analysis of the mRS shows that treatment with TF0023 is positive compared with placebo (mRS score of 0 to 2 indicates functional independence), Part B will start to enroll patients. If the analysis shows that treatment with TF0023 is not positive compared with placebo (mRS score >2), Part B will not enroll any patients. Treatment group assignment for the Week 16 interim analysis will remain blinded to the Investigator and the patient throughout the duration of the study. Part B (Dose-Range-Finding) In Part B (dose-range-finding), approximately 400 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 150 will be randomized in a 1:1 ratio to Group B (middle dose of TF0023 or placebo twice daily) or Group C (low dose of TF0023 or placebo twice daily ). Patients will be further randomized in a 2:1 ratio within each treatment group: Group B - TF0023 middle dose bid [50 patients] or placebo [25 patients]) and Group C (TF0023 low dose bid [50 patients] or placebo [25 patients]). The study design in Part B will be the same as used in Part A. Each patient enrolled in either Group B or Group C will receive study treatment in a double blind manner for 16 weeks starting between 3 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer the correct number of sprays/dose of active treatment or placebo twice daily (approximately every 12 hours) depending on the assigned treatment group. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the EOS at Week 32. That is, patients who were receiving active treatment during the double-blinded period will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit.
Old
This randomized, double-blind (within dose), placebo-controlled, parallel group study will be conducted in 2 parts to evaluate the efficacy and safety of TF0023 spray versus placebo in functional improvement in patients with ischemic strokes. Part A will evaluate the safety and efficacy of TF0023 spray in a higher dose . Efficacy will be assessed by the change in modified Rankin Scale (mRS) score from baseline to Week 16. At Week 16, a blinded interim analysis will be performed to determine if TF0023 shows positive results with a higher proportion of patients in the TF0023 group showing a more favorable outcome compared with the placebo group. If the results are positive, then Part B will be initiated to further evaluate safety and efficacy of TF0023 spray as well as to determine the best dosing regimen for the signs and symptoms and functional improvement of patients with ischemic strokes. Part A (Proof-of-Concept) In Part A (proof-of-concept), approximately 200 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 75 will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 [50 patients] and placebo [25 patients]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer 20 sprays/dose of either TF0023 or placebo twice daily (approximately every 12 hours). Each patient or caregiver in Group A will administer the 20 sprays of study treatment as follows: 4 sprays around the neck, 2 sprays to the left shoulder, 2 sprays to the right shoulder, 6 sprays to the chest, 3 sprays to the left leg, and 3 sprays to the right leg. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the end of the study (EOS) at Week 32. That is, patients who were receiving active treatment will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit. An interim analysis will be performed using the data collected through the study up to and including the Week 16 visit. If the analysis of the mRS shows that treatment with TF0023 is positive compared with placebo (mRS score of 0 to 2 indicates functional independence), Part B will start to enroll patients. If the analysis shows that treatment with TF0023 is not positive compared with placebo (mRS score >2), Part B will not enroll any patients. Treatment group assignment for the Week 16 interim analysis will remain blinded to the Investigator and the patient throughout the duration of the study. Part B (Dose-Range-Finding) In Part B (dose-range-finding), approximately 400 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 150 will be randomized in a 1:1 ratio to Group B (10 sprays/dose of TF0023 or placebo twice daily) or Group C (5 sprays/dose of TF0023 or placebo twice daily ). Patients will be further randomized in a 2:1 ratio within each treatment group: Group B - TF0023 10 Sprays/dose bid [50 patients] or placebo [25 patients]) and Group C (TF0023 5 Sprays/dose bid [50 patients] or placebo [25 patients]). The study design in Part B will be the same as used in Part A. Each patient enrolled in either Group B or Group C will receive study treatment in a double blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer the correct number of sprays/dose of active treatment or placebo twice daily (approximately every 12 hours) depending on the assigned treatment group. Each patient or caregiver in Group B will administer the study treatment as follows: 2 sprays to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 6 sprays to the chest close to the neck twice daily for a total of 20 sprays/day. Each patient or caregiver in Group C will administer the study treatment as follows: 1 spray to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 2 sprays to the chest twice daily for a total of 10 sprays/day. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the EOS at Week 32. That is, patients who were receiving active treatment during the double-blinded period will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit.
2 Aug '16
The description was updated.
New
This randomized, double-blind (within dose), placebo-controlled, parallel group study will be conducted in 2 parts to evaluate the efficacy and safety of TF0023 spray versus placebo in functional improvement in patients with ischemic strokes. Part A will evaluate the safety and efficacy of TF0023 spray in a higher dose . Efficacy will be assessed by the change in modified Rankin Scale (mRS) score from baseline to Week 16. At Week 16, a blinded interim analysis will be performed to determine if TF0023 shows positive results with a higher proportion of patients in the TF0023 group showing a more favorable outcome compared with the placebo group. If the results are positive, then Part B will be initiated to further evaluate safety and efficacy of TF0023 spray as well as to determine the best dosing regimen for the signs and symptoms and functional improvement of patients with ischemic strokes. Part A (Proof-of-Concept) In Part A (proof-of-concept), approximately 200 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 75 will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 [50 patients] and placebo [25 patients]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer 20 sprays/dose of either TF0023 or placebo twice daily (approximately every 12 hours). Each patient or caregiver in Group A will administer the 20 sprays of study treatment as follows: 4 sprays around the neck, 2 sprays to the left shoulder, 2 sprays to the right shoulder, 6 sprays to the chest, 3 sprays to the left leg, and 3 sprays to the right leg. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the end of the study (EOS) at Week 32. That is, patients who were receiving active treatment will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit. An interim analysis will be performed using the data collected through the study up to and including the Week 16 visit. If the analysis of the mRS shows that treatment with TF0023 is positive compared with placebo (mRS score of 0 to 2 indicates functional independence), Part B will start to enroll patients. If the analysis shows that treatment with TF0023 is not positive compared with placebo (mRS score >2), Part B will not enroll any patients. Treatment group assignment for the Week 16 interim analysis will remain blinded to the Investigator and the patient throughout the duration of the study. Part B (Dose-Range-Finding) In Part B (dose-range-finding), approximately 400 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 150 will be randomized in a 1:1 ratio to Group B (10 sprays/dose of TF0023 or placebo twice daily) or Group C (5 sprays/dose of TF0023 or placebo twice daily ). Patients will be further randomized in a 2:1 ratio within each treatment group: Group B - TF0023 10 Sprays/dose bid [50 patients] or placebo [25 patients]) and Group C (TF0023 5 Sprays/dose bid [50 patients] or placebo [25 patients]). The study design in Part B will be the same as used in Part A. Each patient enrolled in either Group B or Group C will receive study treatment in a double blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer the correct number of sprays/dose of active treatment or placebo twice daily (approximately every 12 hours) depending on the assigned treatment group. Each patient or caregiver in Group B will administer the study treatment as follows: 2 sprays to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 6 sprays to the chest close to the neck twice daily for a total of 20 sprays/day. Each patient or caregiver in Group C will administer the study treatment as follows: 1 spray to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 2 sprays to the chest twice daily for a total of 10 sprays/day. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the EOS at Week 32. That is, patients who were receiving active treatment during the double-blinded period will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit.
Old
This randomized, double-blind (within dose), placebo-controlled, parallel group study will be conducted in 2 parts to evaluate the efficacy and safety of TF0023 spray versus placebo in functional improvement in patients with ischemic strokes. Part A will evaluate the safety and efficacy of TF0023 spray in a higher dose (280 mg/day). Efficacy will be assessed by the change in modified Rankin Scale (mRS) score from baseline to Week 16. At Week 16, a blinded interim analysis will be performed to determine if TF0023 shows positive results with a higher proportion of patients in the TF0023 group showing a more favorable outcome compared with the placebo group. If the results are positive, then Part B will be initiated to further evaluate safety and efficacy of TF0023 spray as well as to determine the best dosing regimen for the signs and symptoms and functional improvement of patients with ischemic strokes. Part A (Proof-of-Concept) In Part A (proof-of-concept), approximately 200 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 75 will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 [50 patients] and placebo [25 patients]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer 20 sprays/dose of either TF0023 140 mg or placebo twice daily (approximately every 12 hours) for a total daily dose of 280 mg of study treatment. Each patient or caregiver in Group A will administer the 20 sprays of study treatment as follows: 4 sprays around the neck, 2 sprays to the left shoulder, 2 sprays to the right shoulder, 6 sprays to the chest, 3 sprays to the left leg, and 3 sprays to the right leg. Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the end of the study (EOS) at Week 32. That is, patients who were receiving active treatment will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit. An interim analysis will be performed using the data collected through the study up to and including the Week 16 visit. If the analysis of the mRS shows that treatment with TF0023 is positive compared with placebo (mRS score of 0 to 2 indicates functional independence), Part B will start to enroll patients. If the analysis shows that treatment with TF0023 is not positive compared with placebo (mRS score >2), Part B will not enroll any patients. Treatment group assignment for the Week 16 interim analysis will remain blinded to the Investigator and the patient throughout the duration of the study. Part B (Dose-Range-Finding) In Part B (dose-range-finding), approximately 400 patients who are stable per the NIHSS will be screened as early as 3 days (72 hours) after the onset of stroke symptoms and approximately 150 will be randomized in a 1:1 ratio to Group B (10 sprays/dose of TF0023 70 mg/dose or placebo twice daily for a total daily dose of 140 mg) or Group C (5 sprays/dose of TF0023 35 mg/dose or placebo twice daily for a total daily dose of 70 mg). Patients will be further randomized in a 2:1 ratio within each treatment group: Group B - TF0023 70 mg/dose bid [50 patients] or placebo [25 patients]) and Group C (TF0023 35 mg/dose bid [50 patients] or placebo [25 patients]). The study design in Part B will be the same as used in Part A. Each patient enrolled in either Group B or Group C will receive study treatment in a double blind manner for 16 weeks starting between 5 and 10 days after the onset of stroke symptoms (Day 1 of the study). Qualified study personnel will instruct the patients and/or caregivers how to apply the study treatment accurately so that patients or caregivers will administer the correct number of sprays/dose of active treatment or placebo twice daily (approximately every 12 hours) depending on the assigned treatment group. Each patient or caregiver in Group B will administer the study treatment as follows: 2 sprays to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 6 sprays to the chest close to the neck twice daily for a total of 20 sprays (140 mg)/day. Each patient or caregiver in Group C will administer the study treatment as follows: 1 spray to the front of the neck, 1 spray to the left side of the neck, 1 spray to the right side of the neck, 2 sprays to the chest twice daily for a total of 10 sprays (70 mg/day). Patients will return to the study site at Weeks 4, 8, 12, and 16 for efficacy and safety assessments. After the Week 16 assessments have been performed, patients will receive active treatment in an open-label manner starting the next day through the EOS at Week 32. That is, patients who were receiving active treatment during the double-blinded period will continue to receive active treatment, and patients who were receiving placebo will switch to active treatment for the remaining 16 weeks of the study. Patients will receive only one dose of study treatment on the Week 16 visit day. Patients will return to the study site at Week 24 and Week 32 (EOS) for efficacy and safety assessments. An Early Termination visit will occur if the patient is discontinued from the study prematurely. Patients will have a follow-up visit approximately 14 days after the Early Termination visit or the Week 32 (EOS) visit.